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Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes

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ClinicalTrials.gov Identifier: NCT01865305
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This trial is conducted in Europe. The aim of this trial is to compare different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.

Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. Each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments.

Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin degludec/insulin aspart 30 Drug: insulin degludec/insulin aspart 40 Drug: insulin degludec/insulin aspart 50 Drug: insulin degludec Drug: insulin aspart Drug: biphasic insulin aspart 30 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Multiple Period Crossover Trial Comparing Insulin 454 and Insulin Aspart Premixes With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared With Biphasic Insulin Aspart 30 (NovoMix® 30) in Male Subjects With Type 1 and Type 2 Diabetes Mellitus
Study Start Date : September 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trial part 1 Drug: insulin degludec/insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin).

Drug: insulin degludec/insulin aspart 40
Single dose administrated subcutaneously (s.c., under the skin).

Drug: insulin degludec/insulin aspart 50
Single dose administrated subcutaneously (s.c., under the skin).

Drug: insulin degludec
Single dose administrated subcutaneously (s.c., under the skin).

Drug: insulin aspart
Single dose administrated subcutaneously (s.c., under the skin).

Drug: biphasic insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin) as comparator.

Experimental: Trial part 2 Drug: insulin degludec/insulin aspart 40
Single dose administrated subcutaneously (s.c., under the skin).

Drug: insulin degludec/insulin aspart 50
Single dose administrated subcutaneously (s.c., under the skin).

Drug: biphasic insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin).




Primary Outcome Measures :
  1. Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes) [ Time Frame: 0-2 hours after dosing ]
  2. Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes) [ Time Frame: 0-24 hours after dosing ]

Secondary Outcome Measures :
  1. Area under the glucose infusion rate curve [ Time Frame: 0-24 hours after dosing ]
  2. Area under the serum insulin degludec concentration curve [ Time Frame: 0-96 hours after dosing ]


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
  • Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
  • ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
  • Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
  • ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:
  • Diagnosed with type 2 diabetes mellitus for at least 12 months
  • Treated with insulin for the last 3 months prior to screening.
  • Body Mass Index (BMI) between 22.0 and 35.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
  • A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865305


Locations
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Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01865305     History of Changes
Other Study ID Numbers: NN5401-1738
2006-002430-37 ( EudraCT Number )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs